Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01165437
Recruitment Status : Completed
First Posted : July 19, 2010
Last Update Posted : February 24, 2011
The Cleveland Clinic
Information provided by:
Summit Doppler Systems, Inc.

Brief Summary:

Peripheral arterial disease (PAD) is a highly prevalent medical condition. Patients with PAD are usually diagnosed on the basis of the ankle-brachial index. The ankle-brachial index is the ratio of ankle pressure to arm pressure after measurement of blood pressures in the arms and legs using a Doppler device. The need for dedicated equipment and trained personnel, along with the time required to perform the test, have been identified as barriers to widespread implementation of ankle-brachial index screening. The use of automated oscillometric devices for blood pressure measurement has been applied to leg pressure measurement and determination of the ankle-brachial index with variable success. It will be beneficial to investigate a reliable oscillometric-based procedure that can accurately measure leg pressures for the ankle-brachial index across the entire spectrum of PAD severity.

In a previous pilot study completed in 2009 (IRB 08-823), the investigators gathered data from N=60 subjects which allowed for mathematical analysis of oscillometric waveforms derived from the lower extremities as compared to Doppler-based measurements of blood pressure. We used signal processing analysis and regression techniques to develop a two-step algorithm which will allow for accurate interpretation of oscillometric waveforms in normal/mild vs. moderate/severely diseased limb and accurate calculation of ankle pressure across the spectrum of peripheral artery disease severity.

This proposed project will validate this novel oscillometric ABI algorithm in a population of patients who have been identified as at risk for PAD and for whom screening ABI has been recommended by multiple professional organizations (AHA/ACC and American Diabetes Association). Arm, ankle, and toe pressure measurements will be made in the supine position using Doppler, oscillometric methods, and a photoplethysmographic sensor. The ankle-brachial index and toe-brachial index will be calculated.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Device: Blood Pressure Measurement

Study Type : Observational
Estimated Enrollment : 161 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Validation of a Novel Oscillometric-Based Algorithm for Determination of the Ankle-Brachial Index
Study Start Date : October 2010
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Suspected Arterial Disease
Patients with known or suspected arterial disease and patients screened using AHA/ACC criteria for P.A.D.
Device: Blood Pressure Measurement
Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the non-invasive vascular laboratory or another outpatient clinic in the Heart and Vascular Institute at Cleveland Clinic.

Inclusion Criteria:

  • At least 70 years of age
  • At least 50 years of age with a history of diabetes mellitus or tobacco smoking (>100 cigarettes in their lifetime)
  • Ambulatory Outpatient

Exclusion Criteria:

  • Unable to give informed consent
  • Unable to lie supine for at least 15 minutes
  • Known non-compressible vessels on prior laboratory studies (ABI>1.3 on either side)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01165437

United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Summit Doppler Systems, Inc.
The Cleveland Clinic

Responsible Party: David C. Jones, Summit Doppler Systems, Inc. Identifier: NCT01165437     History of Changes
Other Study ID Numbers: CCF IRB 10-513
First Posted: July 19, 2010    Key Record Dates
Last Update Posted: February 24, 2011
Last Verified: February 2011

Keywords provided by Summit Doppler Systems, Inc.:

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases